AnesthesiaPhase 4NCT02289391
Effect of Dexmedetomidine on Levels of Plasma Inflammatory Factor in Asthma Patients Undergoing General Anesthesia
A Phase 4 study testing Anesthesia induction, Anesthesia maintenance and Assisted anesthesia in people with Anesthesia and Asthma, run by Second Affiliated Hospital of Xi'an Jiaotong University.
Trial summary
The study try to illustrate the possible mechanisms of tending to induce airway spasms and the impact of dexmedetomidine on inflammatory reaction in general anesthesia patients with asthma，by detecting the differences of plasma inflammatory factor interleukin(IL)-4, IL-5, IL-13, IL-17, IL-33, MBP and immunoglobulin… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia, Asthma
- What is being tested?
- Anesthesia induction, Anesthesia maintenance and Assisted anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obtain informed consent
- Elective general anesthesia surgery, surgery time 1 ~ 3 hours.
- 20 patients with a history of asthma.
- 60 patients with no history of asthma.
- American Society of Anesthesiologists (ASA)classification:class I~II.
- Aged between 18 and 65 years old.
Who cannot join
- SBP≥180 mmHg or <90 mmHg, DBP≥110 mmHg or <60 mmHg.
- Serious heart, brain, liver, kidney, lung, endocrine diseases or serious infections.
- Hematopoietic dysfunction or bleeding tendency and hemorrhagic disease.
- A neuromuscular system disease.
- Airway and lung surgery.
- Predict possible or happened difficult airway.
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- Immune function defect.
- Sure/suspected abuse of narcotic analgesics or drugs or alcohol dependence.
- The test drug allergy or have other contraindications in patients.
- Childbearing age women not to take appropriate contraception, pregnancy or lactation.
- Participated in other clinical drug research in the last 30 days.
About this study
Official title: Effect of Dexmedetomidine on Levels of Plasma Inflammatory Factor in Asthma Patients Undergoing General Anesthesia-single Center,Randomized,Double-blind，Controlled Trial
The study try to illustrate the possible mechanisms of tending to induce airway spasms and the impact of dexmedetomidine on inflammatory reaction in general anesthesia patients with asthma，by detecting the differences of plasma inflammatory factor interleukin(IL)-4, IL-5, IL-13, IL-17, IL-33, MBP and immunoglobulin E(IgE) levels between asthma patients and non-asthma patients.
- Conditions
- Anesthesia, Asthma
- Being tested
- Anesthesia induction, Anesthesia maintenance, Assisted anesthesia
- Keywords
- Dexmedetomidine, Inflammatory factor, Inflammatory mediator, Cytokines, Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia inductionDrug
-Intravenous injection midazolam 0.05 mg/Kg,fentanyl 4μg/Kg,etomidate 0.2 mg/Kg,cisatracurium 0.15 mg/Kg in proper order.
Anesthesia maintenanceDrug
- Continuous intravenous remifentanil O.2μg/(kg•h) and propofol 3~8mg/(kg•h).
- Intermittent intravenous atracurium 0.05mg/kg. Maintain partial pressure of carbon dioxide(PETCO2) to 30~40 mmHg and bispectral index (BIS) to 45~60.
Assisted anesthesiaDrug
Intervention 'Assisted anesthesia' has been included in Arm Descriptions.
| Study group | Role | What they receive |
|---|---|---|
| non-asthma group | Placebo comparator | * Non-asthma history
* Infusion of normal saline(1μg/kg) at 10 minutes before anesthesia induction.
* Infusion of normal saline at 0.4μg•kg-1•h-1during anesthesia maintenance.
* Stop infusion of normal saline at 10 minutes before the end of surgery. Receives: Drug: Anesthesia induction; Drug: Anesthesia maintenance |
| Dexmedetomidine A | Experimental | * With a history of asthma
* Infusion of dexmedetomidine(1μg/kg) at 10 minutes before anesthesia induction.
* Infusion of dexmedetomidine at 0.4μg•kg-1•h-1during anesthesia maintenance.
* Stop infusion of dexmedetomidine at 10 minutes before the end of surgery. Receives: Drug: Anesthesia induction; Drug: Anesthesia maintenance; Drug: Assisted anesthesia |
| Dexmedetomidine B | Experimental | * With a history of asthma
* Infusion of dexmedetomidine(1μg/kg) at 10 minutes before anesthesia induction.
* Infusion of dexmedetomidine at 0.7μg•kg-1•h-1during anesthesia maintenance.
* Stop infusion of dexmedetomidine at 10 minutes before the end of surgery. Receives: Drug: Anesthesia induction; Drug: Anesthesia maintenance; Drug: Assisted anesthesia |
| Control group | Placebo comparator | * With a history of asthma
* Infusion of normal saline(1μg/kg) at 10 minutes before anesthesia induction.
* Infusion of normal saline at 0.4μg•kg-1•h-1during anesthesia maintenance.
* Stop infusion of normal saline at 10 minutes before the end of surgery. Receives: Drug: Anesthesia induction; Drug: Anesthesia maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-4，IL-5，IL-13, IL-17, IL-33 concentration in the Plasma
Measured: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
Histamine concentration
Measured: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
Myelin Basic Protein concentration （MBP)
Measured: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
IgE concentration
Measured: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
Secondary outcomes (3)
Mean arterial pressure（MAP）
Measured: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
Heart rate（HR）
Measured: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
Respiratory rate（RR）
Measured: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- NIU XIAOLI, Principal investigator, The second affiliated hospital of xi 'an jiaotong university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289391
- Sponsor's protocol ID
- Dexmedetomidine-14115
- Status last verified
- Nov 2014
- First submitted
- 10 Nov 2014
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Barnes PJ. The cytokine network in asthma and chronic obstructive pulmonary disease. J Clin Invest. 2008 Nov;118(11):3546-56. doi: 10.1172/JCI36130.
PubMed 18982161Saito A, Okazaki H, Sugawara I, Yamamoto K, Takizawa H. Potential action of IL-4 and IL-13 as fibrogenic factors on lung fibroblasts in vitro. Int Arch Allergy Immunol. 2003 Oct;132(2):168-76. doi: 10.1159/000073718.
PubMed 14600429Wen FQ, Kohyama T, Liu X, Zhu YK, Wang H, Kim HJ, Kobayashi T, Abe S, Spurzem JR, Rennard SI. Interleukin-4- and interleukin-13-enhanced transforming growth factor-beta2 production in cultured human bronchial epithelial cells is attenuated by interferon-gamma. Am J Respir Cell Mol Biol. 2002 Apr;26(4):484-90. doi: 10.1165/ajrcmb.26.4.4784.
PubMed 11919085Laporte JC, Moore PE, Baraldo S, Jouvin MH, Church TL, Schwartzman IN, Panettieri RA Jr, Kinet JP, Shore SA. Direct effects of interleukin-13 on signaling pathways for physiological responses in cultured human airway smooth muscle cells. Am J Respir Crit Care Med. 2001 Jul 1;164(1):141-8. doi: 10.1164/ajrccm.164.1.2008060.
PubMed 11435252Taniguchi T, Kidani Y, Kanakura H, Takemoto Y, Yamamoto K. Effects of dexmedetomidine on mortality rate and inflammatory responses to endotoxin-induced shock in rats. Crit Care Med. 2004 Jun;32(6):1322-6. doi: 10.1097/01.ccm.0000128579.84228.2a.
PubMed 15187514Kumar RK, Herbert C, Yang M, Koskinen AM, McKenzie AN, Foster PS. Role of interleukin-13 in eosinophil accumulation and airway remodelling in a mouse model of chronic asthma. Clin Exp Allergy. 2002 Jul;32(7):1104-11. doi: 10.1046/j.1365-2222.2002.01420.x.
PubMed 12100061
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on Levels of Plasma Inflammatory Factor in Asthma Patients Undergoing General Anesthesia-single Center,Randomized,Double-blind，Controlled Trial
- ClinicalTrials.gov ID
- NCT02289391
- Acronym / sponsor ID
- Dexmedetomidine-14115
- Conditions
- Anesthesia, Asthma
- Keywords
- Dexmedetomidine, Inflammatory factor, Inflammatory mediator, Cytokines, Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 13 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study try to illustrate the possible mechanisms of tending to induce airway spasms and the impact of dexmedetomidine on inflammatory reaction in general anesthesia patients with asthma，by detecting the differences of plasma inflammatory factor interleukin(IL)-4, IL-5, IL-13, IL-17, IL-33, MBP and immunoglobulin E(IgE) levels between asthma patients and non-asthma patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| non-asthma group | Placebo comparator | Drug: Anesthesia induction, Drug: Anesthesia maintenance* Non-asthma history * Infusion of normal saline(1μg/kg) at 10 minutes before anesthesia induction. * Infusion of normal saline at 0.4μg•kg-1•h-1during anesthesia maintenance. * Stop infusion of normal saline at 10 minutes before the end of surgery. |
| Dexmedetomidine A | Experimental | Drug: Anesthesia induction, Drug: Anesthesia maintenance, Drug: Assisted anesthesia* With a history of asthma * Infusion of dexmedetomidine(1μg/kg) at 10 minutes before anesthesia induction. * Infusion of dexmedetomidine at 0.4μg•kg-1•h-1during anesthesia maintenance. * Stop infusion of dexmedetomidine at 10 minutes before the end of surgery. |
| Dexmedetomidine B | Experimental | Drug: Anesthesia induction, Drug: Anesthesia maintenance, Drug: Assisted anesthesia* With a history of asthma * Infusion of dexmedetomidine(1μg/kg) at 10 minutes before anesthesia induction. * Infusion of dexmedetomidine at 0.7μg•kg-1•h-1during anesthesia maintenance. * Stop infusion of dexmedetomidine at 10 minutes before the end of surgery. |
| Control group | Placebo comparator | Drug: Anesthesia induction, Drug: Anesthesia maintenance* With a history of asthma * Infusion of normal saline(1μg/kg) at 10 minutes before anesthesia induction. * Infusion of normal saline at 0.4μg•kg-1•h-1during anesthesia maintenance. * Stop infusion of normal saline at 10 minutes before the end of surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Obtain informed consent
- Elective general anesthesia surgery, surgery time 1 ~ 3 hours.
- 20 patients with a history of asthma.
- 60 patients with no history of asthma.
- American Society of Anesthesiologists (ASA)classification:class I~II.
Key exclusion criteria (11 listed)
- SBP≥180 mmHg or <90 mmHg, DBP≥110 mmHg or <60 mmHg.
- Serious heart, brain, liver, kidney, lung, endocrine diseases or serious infections.
- Hematopoietic dysfunction or bleeding tendency and hemorrhagic disease.
- A neuromuscular system disease.
- Airway and lung surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthesia induction-Intravenous injection midazolam 0.05 mg/Kg,fentanyl 4μg/Kg,etomidate 0.2 mg/Kg,cisatracurium 0.15 mg/Kg in proper order. | Drug | Control group, Dexmedetomidine A, Dexmedetomidine B, non-asthma group |
| Anesthesia maintenance* Continuous intravenous remifentanil O.2μg/(kg•h) and propofol 3~8mg/(kg•h). * Intermittent intravenous atracurium 0.05mg/kg. Maintain partial pressure of carbon dioxide(PETCO2) to 30~40 mmHg and bispectral index (BIS) to 45~60. | Drug | Control group, Dexmedetomidine A, Dexmedetomidine B, non-asthma group |
| Assisted anesthesiaIntervention 'Assisted anesthesia' has been included in Arm Descriptions. | Drug | Dexmedetomidine A, Dexmedetomidine B |
Primary outcome
IL-4，IL-5，IL-13, IL-17, IL-33 concentration in the Plasma
Time frame: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
Histamine concentration
Time frame: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
Myelin Basic Protein concentration （MBP)
Time frame: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
IgE concentration
Time frame: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
3 secondary outcomes
Mean arterial pressure（MAP）
Time frame: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
Heart rate（HR）
Time frame: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
Respiratory rate（RR）
Time frame: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
- Background: PubMed 18982161Barnes PJ. The cytokine network in asthma and chronic obstructive pulmonary disease. J Clin Invest. 2008 Nov;118(11):3546-56. doi: 10.1172/JCI36130.
- Background: PubMed 14600429Saito A, Okazaki H, Sugawara I, Yamamoto K, Takizawa H. Potential action of IL-4 and IL-13 as fibrogenic factors on lung fibroblasts in vitro. Int Arch Allergy Immunol. 2003 Oct;132(2):168-76. doi: 10.1159/000073718.
- Background: PubMed 11919085Wen FQ, Kohyama T, Liu X, Zhu YK, Wang H, Kim HJ, Kobayashi T, Abe S, Spurzem JR, Rennard SI. Interleukin-4- and interleukin-13-enhanced transforming growth factor-beta2 production in cultured human bronchial epithelial cells is attenuated by interferon-gamma. Am J Respir Cell Mol Biol. 2002 Apr;26(4):484-90. doi: 10.1165/ajrcmb.26.4.4784.
- Background: PubMed 11435252Laporte JC, Moore PE, Baraldo S, Jouvin MH, Church TL, Schwartzman IN, Panettieri RA Jr, Kinet JP, Shore SA. Direct effects of interleukin-13 on signaling pathways for physiological responses in cultured human airway smooth muscle cells. Am J Respir Crit Care Med. 2001 Jul 1;164(1):141-8. doi: 10.1164/ajrccm.164.1.2008060.
- Background: PubMed 15187514Taniguchi T, Kidani Y, Kanakura H, Takemoto Y, Yamamoto K. Effects of dexmedetomidine on mortality rate and inflammatory responses to endotoxin-induced shock in rats. Crit Care Med. 2004 Jun;32(6):1322-6. doi: 10.1097/01.ccm.0000128579.84228.2a.
- Background: PubMed 12100061Kumar RK, Herbert C, Yang M, Koskinen AM, McKenzie AN, Foster PS. Role of interleukin-13 in eosinophil accumulation and airway remodelling in a mouse model of chronic asthma. Clin Exp Allergy. 2002 Jul;32(7):1104-11. doi: 10.1046/j.1365-2222.2002.01420.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NIU XIAOLI principal investigator
The second affiliated hospital of xi 'an jiaotong university
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anesthesia induction, Anesthesia maintenance and Assisted anesthesia in people with Anesthesia and Asthma, run by Second Affiliated Hospital of Xi'an Jiaotong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-4，IL-5，IL-13, IL-17, IL-33 concentration in the Plasma (time frame: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02289391, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014.